Quality Specialist, Stability

Why Endo?

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

Job Description Summary

The Senior Quality Specialist, Stability is responsible for overseeing the stability program, including review of stability data trends, predicting product shelf life, preparing documentation for initiating new stability studies, and preparing annual Stability Summary reports for inclusion in APRs. This position will have a role in designating commercial lots to be placed on stability, distribution of samples to approved laboratories for testing as per the monthly pull schedule, and ensuring testing is performed and reported on-time.

Job Description

• Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

  Scope is the Generics business, typically supporting one site

  Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

  Accountability

  Responsibilities

  % of Time

  Stability

• Oversees the receiving and labeling of new stability samples of submission, validation, pilot and experimental batches as well as the distribution of samples designated for testing, per the monthly pull schedule
• Works directly with Planning and QA to designate lots to be placed on stability to meet commercial stability testing commitments
• Performs trending of stability analytical data and predicts shelf life for commercial and pre-commercial products, utilizing appropriate statistical software
• Works directly with the testing laboratories to ensure testing is performed and reported on-time
• Reviews the new product stability protocols; prepares the requisite documentation for initiating new stability studies from AR&D and marketed products
• Performs annual inventory of the samples in the stability chambers and coordinates with QA for initiating the stability studies
• Keeps the Stability database (ScienTek & LIMS) current, in accordance with SOP requirements 
• Performs sample inventory maintenance for each of the active studies
• Coordinates the transfer/shipping of stability samples to alternate testing site

• 60%

  Storage

• May monitor the stability storage rooms and chambers and maintain records, as applicable. Responds to alarm calls as needed for the ignition system

• 20%

  FDA Reporting

• Updates and provides copies of the annual stability summary reports to the RA group for their submission to the FDA in a timely manner

• 10%

  SOPs

• Reviews and updates stability group SOPs as needed

• 10%

  Total

  100%

  Qualifications

  Education & Experience

  Minimal acceptable level of education, work experience and  certifications required for the job

• BS in Chemistry or related discipline with 5+ years of experience in pharmaceutical or related industry

• Knowledge

  Proficiency in a body of information required for the job   

  e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

• Strong familiarity with Drug GMP regulations
• Strong knowledge and proficiency with laboratory computer software used for stability

• Skills

  &

  Abilities

  Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

• Demonstrate flexibility in carrying out a variety of assignments in a high quality work environment
• Ability to complete assigned task with minimum supervision
• Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings
• Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information
• Teamwork - Balances team and individual responsibilities; exhibits objectivity and openness to others' views; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; able to build morale and group commitments to goals and objectives; supports everyone's efforts to succeed
• Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality

• Physical Requirements

  Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

• Noise level in the work environment is usually moderate 
• Work environment is representative of a group laboratory environment
• Frequently required to use hands to finger, handle, or feel
• Occasionally lift and/or move up to 25 pounds
• Specific vision abilities required by this job include close vision and color vision

• Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

EEO Statement:

At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.